- The Food and Drug Administration reported the first shortage of a drug due to the outbreak.
- There were previous concerns that the coronavirus had the potential to disrupt supply chains.
- The FDA is taking special note of almost a dozen products manufactured in China.
The pharmaceutical industry has reported the first shortage of a human drug because of the COVID-19 outbreak, which has now spread to 44 countries in a matter of weeks.
The Food and Drug Administration (FDA) said Friday that the shortage is related to a manufacturing site affected by the coronavirus. The agency declined to identify the drug.
This first shortage is compounding already-existing concerns that the coronavirus has the potential to disrupt the medical supply chain. Some are calling for action to bring more drug manufacturing back to the U.S. as worries grow around the safety of generic drugs made overseas.
The American Pharmacists Association (APhA) tells Changing America no matter where drugs are made, safety for patients is vital.
“The quality, safety, and availability of drugs are paramount for patient safety and outcomes, and they should be treated as a strategic asset, regardless of where they are made,” says Ilisa Bernstein, senior vice president of the Pharmacy Practice and Government Affairs at the APhA. “This includes greater transparency and accountability of where drugs are made, who is making them, and how they rate on safety and quality.”
If you are using medications, especially generic medications, many of which are made overseas, you may want to research the product. Their availability could be affected as countries respond to the coronavirus outbreak. Many active ingredients in these pharmaceuticals are sourced from China and other countries.
In a recently released statement, FDA Commissioner Stephen Hahn says, “The FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.”
Hahn says, since Jan. 24, the FDA has been in touch with more than 180 manufacturers of human drugs, “not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China.”
The FDA is taking special note of 20 products “which solely source their active pharmaceutical ingredients or finished drug products from China.”
According to the FDA, they “have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs.”
The FDA is also monitoring 63 manufacturers which represent 72 facilities in China that produce essential medical devices. According to the FDA, “Essential devices are those that may be prone to potential shortage if there is a supply disruption.”
“We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers.” Hahn said. “While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market.”